Trial · NCT05687266
Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations
NCT05687266, Phase 3, Active not recruiting, AstraZeneca
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations. Trials, record NCT05687266. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05687266
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations
- NCT number
- NCT05687266
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 1,350 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- NSCLC
- Interventions
- Datopotamab deruxtecan, Durvalumab, Carboplatin, Pembrolizumab, Cisplatin, Pemetrexed, Paclitaxel
- First posted
- 2023-01-18
- Last updated
- 2026-10-09
- Other registries' IDs
- eudract:2021-004606-21
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) by blinded independent central review (BICR) in the non-squamous TROP2 biomarker positive population | Approximately 3 years | PFS is defined as time from randomisation until progression per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) as assessed by BICR, or death due to any cause. |
| Primary | Overall Survival (OS) in the non-squamous TROP2 biomarker positive population | Approximately 5 years | OS is defined as the time from randomisation until the date of death due to any cause. |
| Primary | PFS by BICR in the non-squamous population | Approximately 3 years | PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause. |
| Primary | OS in the non-squamous population | Approximately 5 years | OS is defined as the time from randomisation until the date of death due to any cause. |
| Secondary | PFS by BICR in ITT and TROP2 biomarker-defined populations | Approximately 3 years | PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause. |
| Secondary | OS in ITT and TROP2 biomarker-defined populations | Approximately 5 years | OS is defined as the time from randomisation until the date of death due to any cause. |
| Secondary | Objective Response Rate (ORR) in ITT, non-squamous and TROP2 biomarker-defined populations | Approximately 5 years | ORR is defined as the proportion of participants who have a confirmed Complete Response (CR) or confirmed Partial Response (PR), as determined by BICR per RECIST 1.1. |
| Secondary | Duration of Response (DoR) in ITT, non-squamous and TROP2 biomarker-defined populations | Approximately 5 years | DoR is defined as the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1, as assessed by BICR and investigator clinical assessment or death due to any cause. |
| Secondary | PFS by investigator in ITT, non-squamous and TROP2 biomarker-defined populations | Approximately 3 years | PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by investigator clinical assessment, or death due to any cause. |
| Secondary | Pharmacokinetics of Dato-DXd when combined with durvalumab and carboplatin. | Approximately 5 years | Concentration of Dato-DXd, total anti-TROP2 antibody, and DXd (payload deruxtecan) in plasma and pharmacokinetic (PK) parameters (such as peak and trough concentrations, as data allow; sparse sampling). |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05687266
GET https://conductscience.org/api/trials/v1/NCT05687266/registered